Recall Z-2594-2014 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
| Date | Sep 5, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| Reason | Identifiers on the label are correct but the label has the incorrect color coding. |
| Root cause | Mixed-up of materials/components |
| Action | Biomet 3i sent an Urgent - Medical Device Removal letter / and by phone call on and dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. If you have any Certain BellaTek Encode Healing Abutment(s) of the affected lot in your practice, please return the abutment(s) to BIOMET 3i in exchange for Cettain BellaTek Encode Healing Abutments, IEHA458 with a proper color stripe. Alternatively, you may return the Certain BellaTek Healing Abutment(s) for full credit. We also ask that you confirm receipt of thi |
| Quantity | 6 units |
| Distribution | US Distribution to NH and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS Biomet 3i, Inc., Dec 20, 2007 |